Diclofenac Sodium
These highlights do not include all the information needed to use DICLOFENAC sodium topical solution safely and effectively. See full prescribing information for DICLOFENAC sodium topical solution. Diclofenac Sodium Topical Solution 1.5% w/w, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
8c0327d4-c0f3-418d-abbe-bf0007e06323
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4018
Application NumberANDA202769
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (6)
DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT